MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for JARIT 250-160 manufactured by Jarit.
[85960148]
Small piece of osteotome that was used during procedure broke off in surgical site and was misplaced. X-ray was completed and the piece was located, but unable to retrieve it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072083 |
| MDR Report Key | 6857549 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-09-02 |
| Date Added to Maude | 2017-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JARIT 250-160 |
| Generic Name | OSTEOTOME |
| Product Code | GFI |
| Date Received | 2017-09-12 |
| Lot Number | 100185-1503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARIT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-12 |